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Measurements to Assess Severity of Epicardial Stenoses (MASES)

This study has suspended participant recruitment.
(IRB Approval on study expired May 28, 2009)
American Heart Association
Information provided by:
University of Cincinnati Identifier:
First received: September 24, 2008
Last updated: September 3, 2010
Last verified: September 2010
Newly developed diagnostic parameters have potential to differentiate between epicardial disease and microvascular dysfunction with the help of anatomical details and physiological endpoints and can be used in present clinical settings.

Condition Intervention Phase
Coronary Artery Disease Device: FFR/CFR and IVUS Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Simultaneous Measurements Of Pressure Gradient, Blood Flow and Percentage Area Stenosis Of Coronary Epicardial Lesions To Assess Severity Of Epicardial Stenosis And Myocardial Infarction

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • to detect ischemic heart disease in patients with abnormal stress tests using MPI with SPECT and to determine the presence of significant epicardial stenosis using coronary angiography with simultaneous physiological pressure and flow measurements [ Time Frame: Upon Diagnostic Angiogram and Flow Wire ]

Secondary Outcome Measures:
  • To compare novel measurements, Pressure Drop Coefficient (CDP) & Lesion Flow Coefficient (LFC), against measured current parameters called Fractional flow reserve (FFR) & Coronary flow reserve (CFR). [ Time Frame: Upon Diagnostic Angiogram and Flow Wire ]

Estimated Enrollment: 76
Study Start Date: December 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CDP LFC
all patients will have this calculation based upon diagnostic parameters with IVUS and FFR and/or CFR
Device: FFR/CFR and IVUS
All patients with clinical indication for cardiac cath will have FFR and IVUS
Other Name: Volcano FFR and IVUS catheters will be used

Detailed Description:
The pressure drop coefficient (CDP) is a functional index based on hyperemic dp and u measurements. The lesion flow coefficient (LFC) combines the functional index CDP with an atomic measure (percentage area stenosis) as a single parameter.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Abnormal Myocardial stress perfusion (SPECT) LV EF > 25%

Exclusion Criteria:

  • LV < or + to 25% Serum Creatinine > 2.5 gm/dL Type II HIT Significant co-morbidities Pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00760630

United States, Ohio
University Hospital
Cincinnati, Ohio, United States, 45219
Department of Veterans Affairs
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
University of Cincinnati
American Heart Association
Principal Investigator: Mohamed Effat, MD University of Cincinnati
Principal Investigator: Kranthi K Kolli, MS University of Cincinnati
Principal Investigator: Massoud Leesar, MD University of Cincinnati
Principal Investigator: Rupak Banerjee, PhD University of Cincinnati
Principal Investigator: Tarek Helmy, MD University of Cincinnati
Principal Investigator: Srikara Pellukhana, BS University of Cincinnati
  More Information

Responsible Party: Imran Arif, MD, UNIVERSITY OF CINCINNATI Identifier: NCT00760630     History of Changes
Other Study ID Numbers: UCIRB08031108
Study First Received: September 24, 2008
Last Updated: September 3, 2010

Keywords provided by University of Cincinnati:
abnormal stress test
fractional flow reserve
pressure drop coefficient
lesion flow coefficient

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on June 23, 2017